Veterinary Medicine Information website

Tolfine 80 mg/ml solution for injection for cattle

Authorised
  • Tolfenamic acid
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Product identification

Medicine name:
Tolfine 80 mg/ml solution for injection for cattle
Active substance:
  • Tolfenamic acid
Target species:
  • Cattle
Route of administration:
  • Intramuscular use
  • Intravenous use

Product details

Active substance and strength:
  • Tolfenamic acid
    80.00
    milligram(s)
    /
    1.00
    millilitre(s)
Pharmaceutical form:
  • Solution for injection
Withdrawal period by route of administration:
  • Intramuscular use
    • Cattle
      • Meat and offal
        20
        day
      • Milk
        0
        hour
  • Intravenous use
    • Cattle
      • Meat and offal
        4
        day
      • Milk
        12
        hour
Anatomical therapeutic chemical veterinary (ATCvet) codes:
  • QM01AG02
Legal status of supply:
  • Veterinary medicinal product subject to veterinary prescription
Authorisation status:
  • Valid
Authorised in:
  • Denmark
Package description:
  • Amber type I glass vial closed with chlorobutyl rubber stoppers and oversealed with an aluminium seal with a polypropylene flip-off cap.Each vial is packaged in a cardboard box.Package sizes:Cardboard box with 1 vial of 250 ml
  • Amber type I glass vial closed with chlorobutyl rubber stopper and oversealed with an aluminium seal with a polypropylene flip-off cap.Each vial is packaged in a cardboard box.Package sizes:Cardboard box with 1 vial of 100 ml
  • Amber type I glass vial closed with chlorobutyl rubber stopper and oversealed with an aluminium seal with a polypropylene flip-off cap.Each vial is packaged in a cardboard box.Package sizes:Cardboard box with 1 vial of 50 ml

Additional information

Entitlement type:
  • Marketing Authorisation
Legal basis of product authorisation:
  • Hybrid application (Article 13(3) of Directive No 2001/82/EC)
Marketing authorisation holder:
  • Vetoquinol Scandinavia AB
Marketing authorisation date:
Manufacturing sites for batch release:
  • Vetoquinol S.A.
Responsible authority:
  • Danish Medicines Agency
Authorisation number:
  • 65946
Date of authorisation status change:
Reference member state:
  • Ireland
Procedure number:
  • IE/V/0661/001
Concerned member states:
  • Austria
  • Belgium
  • Cyprus
  • Czechia
  • Denmark
  • Estonia
  • Finland
  • France
  • Germany
  • Greece
  • Italy
  • Latvia
  • Lithuania
  • Luxembourg
  • Netherlands
  • Poland
  • Portugal
  • Slovakia
  • Slovenia
  • Spain

Documents

Summary of Product Characteristics

English (PDF)
Published on: 6/07/2025
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Danish (PDF)
Published on: 7/04/2025
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Combined File of all Documents

English (PDF)
Published on: 6/07/2025
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